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โ† Trials
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Arthroscopic Versus Open Brostrom for Ankle Instability

RecruitingNAAges 18 Years - 65 YearsAllFederal University of Sรฃo Paulo
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In plain words

What the trial is, and whether it could suit you

Background: Ankle sprains are among the most prevalent lesions in primary care. A substantial number of these ligament lesions will develop ankle instability and require a surgical procedure. The Brostrom-Gould technique is the standard surgical approach for this condition, providing excellent results over the years. Thru the last decades, the arthroscopic Brostrom has gain popularity and support by several studies. Yet, there is no consensus regarding the best procedure to treat ankle instability nowadays. Hypothesis: The arthroscopic Brostrom technique will present better levels of pain and function when compared to the standard open approach. Design: blinded, in parallel groups, multicentric, randomized, clinical trial. Materials and Methods: 98 patients with a diagnosis of chronic ankle instability, referred from primary or secondary health care services, will be assessed and enro

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Individuals must be older than 18 and younger than 65 years of age, both genders; * Participants must be experiencing instability symptoms at the ankle over the last six months; * Clinical diagnosis of ankle instability, defined as the presence of at least one previous ankle sprain associated with a current instability sensation by the patient and the presence of a positive anterior drawer test; the previous lateral ligament injury must be confirmed by Magnetic Resonance Imaging (MRI) findings. Exclusion Criteria: * Previous surgery involving the affected foot or ankle; * History or documented evidence of autoimmune or peripheral vascular diseases; * History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, spondylitis, Reiter Syndrome, etc.); * Associated injuries, such as osteochondral lesions, tendon ruptures and fractures. * Associated instability, such as syndesmotic and medial instability. * Cavovarus foot; * BMI over 35; * Previous infiltration in the ankle over the six months preceding the initial assessment; * Pregnancy; * Any condition that represents a contraindication of the proposed therapies; * Impossibility or incapacity to sign the informed Consent Form; * History or documented evidence of blood coagulation disorders (including treatment with anti-coagulants, but excluding aspirin); * Use of heart pacemaker; * Presence of infectious process (superficial on skin and cellular tissue, or deep in the bone) in the region to be treated;
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What it tests

  • Arthroscopic Brostrom
  • Open Brostrom
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Where

2 sites
Federal University of Minas Gerais
Belo Horizonte, Brazil
Federal University of Sao Paulo
Sรฃo Paulo, Brazil
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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